A Phase 1 Study of SHR-A2102 in Subjects With Advanced Solid Tumors.

NCT ID: NCT05735275

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-03
• Study Completion Date: 2025-08-31

Brief Summary

This is a first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy

Conditions

Advanced Or Metastatic Solid Tumor Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-A2102 Does Escalation and Expansion

Group Type: EXPERIMENTAL

SHR-A2102

Intervention Type: DRUG

All participants receive SHR-A2102 alone.

Interventions

SHR-A2102

All participants receive SHR-A2102 alone.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand and the willingness to sign a written informed consent document；

2. Aged ≥18 years old;

3. Histologically or cytologically confirmed advanced or metastatic malignant tumor;

4. Presence of at least one measurable lesion in agreement to RECIST criteria;

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;

6. Life expectancy ≥3 months;

7. Adequate organ performance based on laboratory blood tests;

8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria

1. Previous received anti-cancer systemic therapy including chemo-therapy, radiation therapy, target therapy or immuno-therapy within 4 weeks before the first dose;

2. Previous received experimental medication or therapy within 4 weeks before the first dose;

3. Previous therapeutic surgery within 4 weeks;

4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.

5. Known allergic to any compound of SHR-A2102;

6. Patients with uncontrolled or active brain metastasis；

7. Patients with clinical significant lung disease;

8. Patients with history of autoimmune diseases;

9. Known active hepatitis B or C infection;

10. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qi Zhang

Role: CONTACT

qi.zhang@hengrui.com

+0518-81220121

Other Identifiers

SHR-A2102-I-101

Identifier Type: -

Identifier Source: org_study_id